Benefit-Risk Assessment in Drug Regulatory Decision-Making

Under FDARA 2017, FDA committed to furthering implementation of structured benefit-risk assessment into drug review

Commitments on Enhancing Benefit-Risk Assessment

• Continue implementation of the Benefit-Risk Framework
• Participate in stakeholder meetings
• Draft guidance on benefit-risk assessment
• Revise relevant MAPPs and SOPPs
• Conduct second evaluation of Benefit-Risk Framework

Additional Opportunities to Enhance FDA’s Benefit-Risk Assessment

• Improving accessibility for approved products
• Use to support Advisory Committee meetings
• Exploring additional tools to support assessment

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Image credit: FDA